Using mobile technology to deliver a cognitive behaviour therapy-informed intervention in early psychosis (Actissist): study protocol for a randomised controlled trial.
Using mobile technology to deliver a cognitive behaviour therapy-informed intervention in early psychosis (Actissist): study protocol for a randomised controlled trial.
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DOI：
10.1186/s13063-015-0943-3
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发表时间：
2015-09-10
期刊：
影响因子：
2.5
通讯作者：
Haddock G
中科院分区：
文献类型：
--
作者：
Bucci S;Barrowclough C;Ainsworth J;Morris R;Berry K;Machin M;Emsley R;Lewis S;Edge D;Buchan I;Haddock G
认知行为疗法（CBT）被推荐用于治疗精神病；然而，只有一小部分服务使用者能够获得这种干预。使用软件应用程序（apps）的智能手机技术可以增加对精神病的心理治疗方法。本文报道了基于智能手机的CBT临床试验的方案开发。我们提出了一项研究方案，描述了一项单盲随机对照试验，比较了认知行为治疗软件应用程序（Actissist）加常规治疗（TAU）与症状监测软件应用程序（ClinTouch）加早期精神病的TAU。该研究包括一个为期12周的干预期。我们的目标是招募并随机分配36名参与者，他们在英国英格兰西北部注册了早期干预服务（EIS），每组试验的比例为2:1。我们的主要目标是确定在早期精神病患者中，Actissist应用程序是否可行并可接受使用。次要目的是确定行动者是否对首发精神病（FEP）复发的预测因素有影响，并提高使用者的授权、功能和生活质量。评估将在基线、12周（治疗后）和22周（治疗后10周）进行，评估人员对治疗情况一无所知。该试验将报告Actissist的可行性和可接受性，并比较随机分组的结果。该研究还结合了参与Actissist试验的半结构化访谈，这些访谈将进行定性分析，以告知Actissist协议和应用程序的未来发展。据我们所知，这是第一个测试早期精神病的cbt智能手机应用程序的可行性、可接受性、吸收、消耗和潜在功效的对照试验。旨在提供心理知情干预的移动应用程序提供了新的可能性，可以在一系列严重的心理健康问题上扩大传统心理健康服务的范围，并提供有关现有护理的选择。ISRCTN34966555。首次注册日期：2014年6月12日。
Cognitive behaviour therapy (CBT) is recommended for the treatment of psychosis; however, only a small proportion of service users have access to this intervention. Smartphone technology using software applications (apps) could increase access to psychological approaches for psychosis. This paper reports the protocol development for a clinical trial of smartphone-based CBT. We present a study protocol that describes a single-blind randomised controlled trial comparing a cognitive behaviour therapy-informed software application (Actissist) plus Treatment As Usual (TAU) with a symptom monitoring software application (ClinTouch) plus TAU in early psychosis. The study consists of a 12-week intervention period. We aim to recruit and randomly assign 36 participants registered with early intervention services (EIS) across the North West of England, UK in a 2:1 ratio to each arm of the trial. Our primary objective is to determine whether in people with early psychosis the Actissist app is feasible to deliver and acceptable to use. Secondary aims are to determine whether Actissist impacts on predictors of first episode psychosis (FEP) relapse and enhances user empowerment, functioning and quality of life. Assessments will take place at baseline, 12 weeks (post-treatment) and 22-weeks (10 weeks post-treatment) by assessors blind to treatment condition. The trial will report on the feasibility and acceptability of Actissist and compare outcomes between the randomised arms. The study also incorporates semi-structured interviews about the experience of participating in the Actissist trial that will be qualitatively analysed to inform future developments of the Actissist protocol and app. To our knowledge, this is the first controlled trial to test the feasibility, acceptability, uptake, attrition and potential efficacy of a CBT-informed smartphone app for early psychosis. Mobile applications designed to deliver a psychologically-informed intervention offer new possibilities to extend the reach of traditional mental health service delivery across a range of serious mental health problems and provide choice about available care. ISRCTN34966555. Date of first registration: 12 June 2014.